Effectiveness of an Intervention Based on Arts In Health in the Quality of Life of People With Fibromyalgia.

NCT05993663 | Unknown

• 1 other identifier: 23/133-P
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this intervention is to measure the impact of a 12-session intervention with Arts in Health methodology on the quality of life of the population with fibromyalgia. The main questions it aims to answer are:

• To know if the methodology of Arts in Health is effective for the improvement of the functional capacity of people with fibromyalgia
• Which are the most effective techniques within this intervention During the intervention, the participants will take part in mindfulness sessions, dance, visual thinking strategies, aimed at a greater understanding of the disease and the development of healthy habits. The results of this intervention are compared with a control group, in which the same scales and instruments will be passed in the same period of time. To complete the information gathering, a focus group will be held to obtain qualitative information about the experience of the participants.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Arts in Health; Mindfulness; Visual Thinking Strategies; Revised Fibromyalgia Impact Questionnaire (FIQ-R)

Outcome Measures

Primary Outcomes (2)

• Functional capacity

  Functional capacity with respect to pain management, measured with the Revised Fibromyalgia Impact Questionnaire (FIQ-R)

  The first and last days of the intervention and 6 months after intervention.

• Life quality

  Quality of life perceived by the participants, measured with the EUROQOL

  The first and last days of the intervention and 6 months after intervention.

Secondary Outcomes (6)

• Anxiety

  1 month before the intervention, last intervention day and 6 months after intervention.

• Emotional well-being

  1 month before the intervention, last intervention day and 6 months after intervention.

• Depression

  1 month before the intervention, last intervention day and 6 months after intervention.

• Social support

  1 month before the intervention, last intervention day and 6 months after intervention.

• Drug consumption

  During the 6 months before the intervention and the 6 months after the intervention.

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention groups that will receive 12 Arts in Health session. There will be four groups of 15 individuals for reaching the needed sample size.

Behavioral: Arts in health group intervention

Control group

NO INTERVENTION

Control groups. Participants in these groups won't receive any group intervention, just regular health care.

Interventions

Arts in health group intervention BEHAVIORAL

12 sessions using the Arts in Health methodology with the aim of having a better understanding of the disease, developing healthy lifestyle habits and greater emotional intelligence. Visual thinking strategies, game based activities, mindfulness and dance will be used

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals diagnosed with fibromyalgia (M79.1) or diagnosed with fibromyalgia and chronic fatigue syndrome (T78.40 and M79.7)
• Over 18 years old.
• They agree to participate in the study and sign the informed consent.

You may not qualify if:

• Serious concomitant rheumatological pathology, that is to say, that this involves a much more important functional disability than that caused by the fibromyalgia pathology itself.
• Serious psychiatric pathology \[according to V Diagnostical and Statical Manual of Mental Disorders (DSM-V) criteria\] that could make it difficult to participate in the sessions and follow the study. Or that due to his psychiatric diagnosis, participation in a group was not advisable because of the negative impact it could cause.
• Having previously participated in the group education project for people with fibromyalgia in Figueres Health Care Center.
• Users who present a language barrier that makes good communication impossible.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Agència de Salut Pública de Catalunya (ASPCAT): collaborator
• Institut Català de la Salut: collaborator
• Servei de Museus i Protecció de Béns Mobles: collaborator
• Museu de l'Empordà: collaborator
• Adhoc Cultura: collaborator

Study Sites (1)

ABS Figueres

Figueres, Girona, 17600, Spain

RECRUITING

Related Publications (48)

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MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Judit Ferragutcasas Butiña

CONTACT

600234302; jferragutcasa.girona.ics@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single intervention will be carried out for the 60 people who are part of the intervention groups, which will be 4 in total

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 15, 2023
• Study Start: October 2, 2023
• Primary Completion: August 15, 2025
• Study Completion: December 30, 2025
• Last Updated: August 15, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)